Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

Inclusion Criteria:

Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
Written informed consent

Exclusion Criteria:

Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
Subjects taking medications prohibited by the protocol
Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Vaccination sub-study:

Inclusion criteria

Informed consent
Actively enrolled in the COMB157G2399 Study
12 weeks of continuous treatment within the COMB157G2399 Study
prior vaccination history as per protocol-defined

Exclusion criteria

known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
allergies to egg or shellfish
any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit

Other protocol-defined inclusion/exclusion criteria may apply